Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55293 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 12, 2006. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.579 is amended by 

adding text and a table to paragraph (b) 

to read as follows: 

§ 180.579 Fenamidone; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

A time-limited tolerance is established 

for residues of the fungicide 

fenamidone, (4H-imidazol-4-one, 3,5- 

dihydro-5-methyl-2-(methylthio)-5- 

phenyl-3-(phenylamino), (S)-) in 

connection with use of the pesticide 

under a section 18 emergency 

exemption granted by EPA. The 

tolerance will expire and is revoked on 

the date specified in the following table: 

Commodity Parts per million Expiration/revocation date 

Carrot ........................................................................................................................................................... 0.20 12/31/2009 

[FR Doc. 06–7956 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0053; FRL–8093–9] 

Fenbuconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

fenbuconazole, a–(2–(4–chlorophenyl)–

ethyl)–a–phenyl–3–(1H–1,2,4–triazole)–

1–propanenitrile, and its metabolites 

RH–9129, cis–5–(4–chlorophenyl)–

dihydro–3–phenyl–3–(1H–1,2,4–

triazole–1–ylmethyl)–2–3H–furanone, 

and RH–9130, trans–5–(4–

chlorophenyl)–dihydro–3–phenyl–3–

(1H–1,2,4–triazole–1–ylmethyl)–2–3H–

furanone, in or on almond; almond, 

hulls; apple; apple wet pomace; banana; 

beet, sugar, dried pulp; beet, sugar, 

molasses; beet, sugar, roots; beet, sugar, 

tops; bushberry subgroup 13B; cattle, 

meat byproducts; citrus, dried pulp; 

citrus, oil; cranberry; fruit, citrus, group 

10; fruit, stone, group 12; goat, meat 

byproducts; grain, aspirated fractions; 

grape; horse, meat byproducts; peanut; 

pecan; sheep, meat byproducts; wheat, 

forage; wheat, grain; wheat, hay; and 

wheat, straw. EPA is also deleting 

several existing tolerances that are no 

longer needed as a result of this action. 

Dow AgroSciences requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 22, 2006. Objections and 

requests for hearings must be received 

on or before November 21, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2005–0053. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The Docket Facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Tony Kish, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9443; e–mail address: 

kish.tony@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 


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55294 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e–CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2005–0053 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 21, 2006. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2005–0053, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on–

line instructions for submitting 

comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of July 20, 

2005, 70 FR 41718 (FRL–7702–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PP 0E6208, PP 

1E6252, PP 1F3989, PP 1F3995, PP 

2F4127, PP 2F4135, PP 2F4154, PP 

3F4914, PP 4F6879, PP 7F4887, PP 

9E5041, and PP 9F6024) by Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, Indiana 46268–

1054. The petition requested that 40 

CFR 180.480 be amended by 

establishing tolerances for combined 

residues of the fungicide fenbuconazole, 

a–(2–(4–chlorophenyl)–ethyl)–a–

phenyl–3–(1H–1,2,4–triazole)–1–

propanenitrile, and its metabolites cis–

5–(4–chlorophenyl)–dihydro–3–

phenyl–3–(1H–1,2,4–triazole–1–

ylmethyl)–2–3H–furanone and trans–5–

(4–chlorophenyl)–dihydro–3–phenyl–

3–(1H–1,2,4–triazole–1–ylmethyl)–2–

3H–furanone, in or on almond at 0.05 

parts per million (ppm) (PP 3F4194); 

almond, hulls at 3.0 ppm (PP 3F4194); 

apple at 0.4 ppm (PP 2F4135); apple, 

wet pomace at 1.0 ppm (PP 2F4135); 

banana at 0.3 ppm (PP 2F4154); 

blueberry at 0.3 ppm (PP 9E5041); 

cranberry at 1.0 ppm (PP 1E6252); fruit, 

citrus, group 10 at 1.0 ppm (PPs 7F4900 

and 4F6879); fruit, stone, group 12 

(except plum, prune) at 2.0 ppm (PP 

1F3989); grape at 1.0 ppm (PP 0E6208); 

pecan at 0.1 ppm (PP 1F3995); plum at 

2.0 ppm (PP 1F3989); plum, prune, 

dried at 7.0 ppm (PP 1F3989); sugar 

beet, dried pulp at 1.0 ppm (PP 7F4887); 

sugar beet, molasses at 0.4 ppm (PP 

7F4887); sugar beet, roots at 0.2 ppm 

(PP 7F4887); sugar beet, tops at 9.0 ppm 

(PP 7F4887); wheat, grain at 0.05 ppm 

(PP 2F4127); and wheat, straw (PP 

2F4127) at 10.0 ppm; establishing 

tolerances for combined residues of the 

fungicide fenbuconazole, a–(2–(4–

chlorophenyl)–ethyl)–a–phenyl–3–(1H–

1,2,4–triazole)–1–propanenitrile, and its 

metabolite a–(2–(4–chloro–3–(D–

glucopyranosyloxy)–phenyl)ethyl)–a–

phenyl–1H–1,2,4–triazole–1–

propanenitrile, in or on peanut at 0.1 

ppm (PP 9F6024) and peanut, hay at 20 

ppm (PP 9F6024); by establishing 

tolerances for combined residues of the 

fungicide fenbuconazole, a–(2–(4–

chlorophenyl)–ethyl)–a–phenyl–3–(1H–

1,2,4–triazole)–1–propanenitrile, and its 

metabolites cis–5–(4–chlorophenyl)–

dihydro–3–phenyl–3–(1H–1,2,4–

triazole–1–ylmethyl)–2–3H–furanone, 

trans–5–(4–chlorophenyl)–dihydro–3–

phenyl–3–(1H–1,2,4–triazole–1–

ylmethyl)–2–3H–furanone, and 4–

chloro–a–hydroxymethyl–a–phenyl–

benzenebutanenitrile in or on fat of 

cattle, goats, hogs, horses, and sheep at 

0.05 ppm (PP 2F4127), and liver of 

cattle, goats, hogs, horses, and sheep at 

0.3 ppm (PP 2F4127). That notice 

included a summary of the petition 

prepared by Dow AgroSciences LLC, the 

registrant. There were no comments 

received in response to the notice of 

filing. 

EPA is also deleting several 

established time–limited tolerances in 

§ 180.480(b) that are no longer needed. 

These revisions are as follows: 

i. Delete the cattle, goat, horse, and 

sheep meat byproducts tolerances, each 

for 0.01 ppm and expiring on December 

31, 2008. These tolerances are replaced 

by permanent tolerances of 0.05 ppm for 

cattle, goat, horse, and sheep meat 

byproducts, respectively. 

ii. Delete the grapefruit tolerance of 

0.5 ppm that expires on December 31, 

2008. It is replaced by a permanent 

tolerance of 1.0 ppm for fruit, citrus, 

group 10. 

iii. Delete the grapefruit, dried pulp 

tolerance of 4.0 ppm that expires on 

December 31, 2008. It is replaced by a 

permanent tolerance of 5.0 ppm for 

citrus, dried pulp. 

iv. Delete the grapefruit, oil tolerance 

of 35 ppm that expires on December 31, 

2008. It is replaced by a permanent 

tolerance of 40.0 ppm for citrus, oil. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 


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FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA–PEST/1997/ 

November/Day–26/p30948.htm, http:// 

www.epa.gov/oppfead1/trac/science, 

http://www.epa.gov/pesticides/ 

factsheets/riskassess.htm, and http:// 

www.epa.gov/pesticides/trac/science/ 

aggregate.pdf. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for tolerances for combined 

residues of fenbuconazole, a–(2–(4–

chlorophenyl)–ethyl)–a–phenyl–3–(1H–

1,2,4–triazole)–1–propanenitrile), and 

its metabolites RH–9129, cis–5–(4–

chlorophenyl)–dihydro–3–phenyl–3–

(1H–1,2,4–triazole–1–ylmethyl)–2–3H–

furanone, and RH–9130, trans–5–(4–

chlorophenyl)–dihydro–3–phenyl–3–

(1H–1,2,4–triazole–1–ylmethyl)–2–3H–

furanone, in or on almond at 0.05 ppm; 

almond, hulls at 1.0 ppm; apple at 0.4 

ppm; apple, wet pomace at 1.0 ppm; 

banana at 0.3 ppm; beet, sugar, dried 

pulp at 1.0 ppm; beet, sugar, molasses 

at 0.4 ppm; beet, sugar, roots at 0.3 ppm; 

beet, sugar, tops at 9.0 ppm; bushberry 

subgroup 13B at 0.3 ppm; cattle, meat 

byproducts at 0.05 ppm; citrus, dried 

pulp at 5.0 ppm; citrus, oil at 40.0 ppm; 

cranberry at 0.5 ppm; goat, meat 

byproducts at 0.05 ppm; fruit, citrus, 

group 10 at 1.0 ppm; fruit, stone, group 

12 at 1.0 ppm; grain, aspirated fractions 

at 6.0 ppm; grape at 1.0 ppm; horse, 

meat byproducts at 0.05 ppm; peanut at 

0.1 ppm; pecan at 0.05 ppm; sheep, 

meat byproducts at 0.05 ppm; wheat, 

forage at 4.0 ppm; wheat, grain at 0.1 

ppm; wheat, hay at 8.0 ppm; and wheat, 

straw at 8.0 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing the tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

fenbuconazole as well as the no–

observed–adverse–effect–level (NOAEL) 

and the lowest–observed–adverse–

effect–level (LOAEL) from the toxicity 

studies can be found at http:// 

www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ–

OPP–2005–0053. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at http://www.epa.gov/ 

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for fenbuconazole used for 

human risk assessment is shown below 

in Table 1 of this document. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENBUCONAZOLE FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario 

Dose Used in Risk Assessment; 

Interspecies and Intraspecies and 

any Traditional UF 

Special FQPA Safety Factor 

(SF); Level of Concern for Risk 

Assessment 

Study; Endpoint and Toxicological Effects 

Acute Dietary (Females 13-49 

years of age) 

NOAEL = 30 mg/kg/day; 

UF = 100; Acute RfD1 = 0.3 mg/kg/ 

day 

Special FQPA SF = 1; 

aPAD = acute RfD1 ÷ Special 

FQPA SF = 0.3 mg/kg/day 

Rat developmental study; 

Developmental LOAEL = 75 mg/ 

kg/day based on increased resorptions and decreased live 

fetuses per dam 

Acute Dietary (General population including infants and 

children) 

No NOAEL was identified; UF is not 

applicable; no Acute RfD1 was 

calculated.

Special FQPA SF is not applicable; no aPAD2 was calculated.No study was selected because 

no appropriate dose and endpoint could be identified for 

this population group 

Chronic Dietary (All populations) NOAEL= 3 mg/kg/day; UF = 100; 

Chronic RfD1 = 0.03 mg/kg/day.

Special FQPA SF = 1; cPAD3 = 

chronic RfD1 ÷ Special FQPA 

SF = 0.03 mg/kg/day.

Rat combined chronic toxicity/ 

carcinogenicity study; 

LOAEL = 30.6 mg/kg/day for 

males and 43.1 mg/kg/day for 

females based on decreased 

body weight gain, increased 

thyroid weight, and 

histopathological lesions in the 

liver and thyroid gland 

Incidental Oral (all durations) No NOAEL was identified; UF is not 

applicable; no RfD1 was calculated.

Special FQPA SF is not applicable; no LOC was determined.No study was selected because 

no registered uses would result in residential exposure 


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55296 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENBUCONAZOLE FOR USE IN HUMAN RISK

ASSESSMENT—Continued 

Exposure Scenario 

Dose Used in Risk Assessment; 

Interspecies and Intraspecies and 

any Traditional UF 

Special FQPA Safety Factor 

(SF); Level of Concern for Risk 

Assessment 

Study; Endpoint and Toxicological Effects 

Long-Term Dermal (several 

months to lifetime) 

Oral study NOAEL= 3 mg/kg/day 

(dermal absorption rate = 4.25%).

Residential LOC for MOE4 = not 

applicable;.

Occupational LOC for MOE = 

100 

Rat combined chronic toxicity/ 

carcinogenicity study; 

LOAEL = 30.6 mg/kg/day for 

males and 43.1 mg/kg/day for 

females based on decreased 

body weight gain, increased 

thyroid weight, and 

histopathological lesions in the 

liver and thyroid gland 

Inhalation (all durations) Oral study NOAEL= 3 mg/kg/day; 

Absorption factor = 100%).

Residential LOC for MOE4 = not 

applicable;.

Occupational LOC for MOE = 

100 

Rat combined chronic toxicity/ 

carcinogenicity study; 

LOAEL = 30.6 mg/kg/day for 

males and 43.1 mg/kg/day for 

females based on decreased 

body weight gain, increased 

thyroid weight, and 

histopathological lesions in the 

liver and thyroid gland 

Cancer (oral, dermal, inhalation) Classification: Under the 1986 cancer classification scheme, fenbuconazole was classified as a Group C - 

Possible Human Carcinogen with a low dose extrapolation model applied to the animal data for the quantification of human risk (Q1*). This was based on increased incidence of hepatocellular adenomas and carcinomas in male and female mice and of thyroid follicular adenomas and combined adenomas/carcinomas 

in male rats. Based on mechanistic data, quantification of risk was derived using combined hepatocellular 

adenomas/carcinomas in female mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)-1, is 3.59 x 

10-3 in human equivalents. 

1RfD means ‘‘Reference Dose’’; 2aPAD means ‘‘acute Population Adjusted Dose’’; 3cPAD means ‘‘chronic Population Adjusted Dose; 4MOE 

means ‘‘Margin of Exposure’’

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have previously 

been established (40 CFR 180.480) for 

the combined residues of fenbuconazole 

and its metabolites RH-9129 and RH9130, in or on a variety of raw 

agricultural commodities. These raw 

agricultural commodities include fat, 

meat, and meat byproducts of cattle, 

goat, hog, horse, and sheep. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

fenbuconazole in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide if 

a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a one-day or 

single exposure. 

The Dietary Exposure Evaluation 

Model (DEEMTM) analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1994-1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII) and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessments: The acute dietary (food 

plus water) assessment was very 

conservative — a screening level, Tier 1 

assessment. It was based on tolerancelevel residues and assumed that 100% 

of each crop was treated with 

fenbuconazole. For water exposure the 

assessment used the estimated 

maximum peak concentration of 

fenbuconazole in surface water that was 

calculated from the requested use 

pattern for cherries, a worst-case 

estimate. The only population subgroup 

that is relevant for this acute assessment 

is females (13-49 years old). 

ii. Chronic (non-cancer) exposure. In 

conducting this chronic dietary risk 

assessment the Dietary Exposure 

Evaluation Model (DEEMTM) analysis 

evaluated the individual food 

consumption as reported by 

respondents in the USDA 1994-1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII) and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: The 

chronic (non-cancer) dietary assessment 

included contributions from both food 

and water. This analysis is more refined 

than the acute dietary assessment in that 

it uses average residues from field trials. 

Due to the manner in which these data 

were submitted and reviewed, multiple 

averages were calculated for many of the 

crops. For these crops the highest 

average was used in the analysis. The 

non-cancer chronic dietary analysis 

assumed 100% crop treated and the 

annual average estimated surface water 

concentration from the cherry use. 

iii. Cancer. The cancer dietary 

assessment used the same food residue 

inputs as those of the non-cancer 

assessment—average residues from field 

trials and 100% crop treated for all 

crops. The water component of this 

assessment used the estimated 30–year 

average surface water concentration 

from the cherry use. 

iv. Anticipated residue information. 

Section 408(b)(2)(E) of the FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide chemicals 

that have been measured in food. If EPA 

relies on such information, EPA must, 

pursuant to section 408(f)(1), require 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. Following the initial data 

submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. For the present 


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action, EPA will issue such data call-ins 

for information relating to anticipated 

residues as are required by FFDCA 

section 408(b)(2)(E) and authorized 

under FFDCA section 408(f)(1). Such 

data call-ins will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Anticipated residue data were used in 

the chronic (non-cancer) and cancer 

dietary risk analyses but not in the acute 

dietary risk analysis. The anticipated 

residues used were the highest perstudy-volume average residue from the 

field trial studies for each crop that were 

submitted by the registrant. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

fenbuconazole in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

fenbuconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the PRZM/EXAMS and SCIGROW models, the estimated 

environmental concentrations (EECs) of 

fenbuconazole for acute exposures are 

estimated to be 20.3 parts per billion 

(ppb) for surface water and 0.031 ppb 

for ground water. The EECs for chronic 

(non-cancer) and for cancer exposures 

are estimated to be 16.5 ppb for surface 

water and 0.031 ppb for ground water. 

3. From non-dietary exposure. Where 

the term ‘‘residential exposure’’ is used 

in this document, it refers to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). However, 

fenbuconazole is not registered for any 

use that will result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Fenbuconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between their pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same, sequence of 

major biochemical events (EPA, 2002). 

In conazoles, however, a variable 

pattern of toxicological responses is 

found. Some are hepatotoxic and 

hepatocarcinogenic in mice. Some 

induce thyroid tumors in rats. Some 

induce developmental, reproductive, 

and neurological effects in rodents. 

Furthermore, the conazoles produce a 

diverse range of biochemical events 

including altered cholesterol levels, 

stress responses, and altered DNA 

methylation. It is not clearly understood 

whether these biochemical events are 

directly connected to their toxicological 

outcomes. Thus, there is currently no 

evidence to indicate that conazoles 

share common mechanisms of toxicity 

and EPA is not following a cumulative 

risk approach based on a common 

mechanism of toxicity for the conazoles. 

For information regarding EPA’s 

procedures for cumulating effects from 

substances found to have a common 

mechanism of toxicity, see EPA’s 

website at http://www.epa.gov/ 

pesticides/cumulative. 

Fenbuconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazole alanine and triazole acetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

fenbuconazole, U.S. EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, triazole 

alanine, and triazole acetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 

fungicide. The risk assessment is a 

highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

(e.g., use of a maximum combination of 

uncertainty factors) and potential 

dietary and non-dietary exposures (i.e., 

high end estimates of both dietary and 

non-dietary exposures). In addition, the 

Agency retained the additional 10X 

FQPA safety factor for the protection of 

infants and children. The assessment 

includes evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

complete risk assessment is found in the 

propiconazole reregistration docket at 

http://www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ–

OPP–2005–0497. 

D. Safety Factor for Infants and 

Children 

1.In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

The data provided no indication of 

increased susceptibility of rats or rabbits 

to in utero and/or postnatal exposure to 

fenbuconazole. In the prenatal 

developmental study in rats and rabbits 

and the 2-generation study in rats, 

effects in the offspring were observed 

only at or above those treatment levels 

which resulted in maternal toxicity. 

The degree of concern for infants and 

children exposed to fenbuconazole in 

utero and/or postnatally is low; there 

are no residual uncertainties. The 

toxicology database for fenbuconazole is 

complete and adequate for risk 

assessment purposes. Acceptable 

developmental studies in rats and 

rabbits and the 2-generation 

reproduction study in rats did not show 

evidence of increased susceptibility in 

offspring exposed to fenbuconazole in 

utero and/or postnatally. A NOAEL for 

acute effects has been selected for the 

subpopulation females (13-49 years old) 

based on developmental effects 

(increased resorptions and decreased 

live fetuses per dam) seen at the LOAEL 

in the developmental rat study. By 

regulating on the effect of concern for 

this subpopulation, the risk assessment 

is protective of potential effects to 

infants and children. No acute effects of 

fenbuconazole were identified in any of 

the other studies. 

3. Conclusion. There is a complete 

toxicity data base for fenbuconazole and 

exposure data are complete or are 

estimated based on data that reasonably 

account for potential exposures. The 


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55298 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

FQPA safety factor was therefore 

removed (i.e., reduced to 1x) in 

assessing the risk posed by 

fenbuconazole, based on the following 

considerations: 

i. There are no toxicology data gaps 

for the assessment of the effects of 

fenbuconazole; a developmental 

neurotoxicity study is not required. 

ii. There is no indication of 

quantitative or qualitative susceptibility 

of rats or rabbits to in utero and/or 

postnatal exposure to fenbuconazole. 

iii. The dietary exposure assessment 

is based on models and input 

parameters designed to be protective of 

human health. 

iv. At this time, there are no registered 

residential uses for fenbuconazole, so 

this type of exposure to infants and 

children is not expected. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute exposure to 

fenbuconazole from dietary (food plus 

water) consumption was calculated only 

for the population subgroup females 

(13-49 years old). It will occupy 3% of 

the aPAD for this subgroup based on a 

95th percentile acute dietary exposure of 

0.009014 mg/kg/day. The surface water 

concentration that was used in this 

analysis was 20.3 ppb. Because of the 

toxicology of fenbuconazole, an acute 

risk analysis is not relevant for the 

general U.S. population or any other 

population subgroup. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has calculated 

that chronic dietary exposure to 

fenbuconazole from food plus water will 

utilize 2% of the cPAD for the general 

U.S. population, 7% of the cPAD for all 

infants (less than 1 year old), and 6% of 

the cPAD for children (1-2 years old). 

There are no residential uses for 

fenbuconazole that result in chronic 

residential exposure to fenbuconazole. 

The surface water concentration of 

fenbuconazole that was used for the 

general U.S. population and each 

population subgroup in this analysis 

was 16.5 ppb. EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD for the general U.S. 

population or any subgroup of it, as 

shown below, in Table 2 of this 

document. 

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) 

EXPOSURE TO FENBUCONAZOLE

Population/ 

Subgroup 

Exposure 

(mg/kg/day) % cPAD 

General U.S. 

Population 0.000666 2 

All Infants (>1 

Year Old) 0.002016 7 

Children (1-2 

Years Old) 0.001795 6 

Children (3-5 

Years Old) 0.001408 5 

Children (6-12 

Years Old) 0.000783 3 

Youth (13-19 

Years Old) 0.000419 1 

Adults (20-49 

Years Old) 0.000525 2 

Adults (50+ 

Years Old) 0.000612 2 

Females (13- 

49 Years 

Old) 0.000539 2 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposures take into account residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

Fenbuconazole is not registered for use 

on any site(s) that would result in 

residential exposure. Therefore, the 

aggregate risks are the sums of the risks 

from food and water, which do not 

exceed the Agency’s level of concern. 

4. Aggregate cancer risk for U.S. 

population. Dietary exposure (food plus 

water) is the only source of exposure to 

fenbuconazole that is expected to be 

chronic (cancer exposure is considered 

to be life-time exposure). The chronic 

(cancer) aggregate exposure and risk 

estimates are based on those for the 

general U.S. population group. In this 

case the risk is based on a cancer 

potency (Q1*) value of 3.59 x 10-3 and 

a dietary exposure to fenbuconazole of 

0.000666 mg/kg/day. The dietary 

exposure is the same as that used for the 

chronic (non-cancer) assessment. The 

estimated cancer risk that resulted from 

this assessment is 2.4 x 10-6. In general, 

the precision which can be assumed for 

cancer risk estimates is best described 

by rounding to the nearest integral order 

of magnitude on the log scale, e.g., 3.16 

x 10-7 to 3.16 x 10-6, expressed as 10-6. 

Risks are generally reported to two 

significant figures in Agency risk 

assessments to allow better 

characterization of changes in risk 

which might result from potential risk 

mitigation. This rounding procedure 

indicates that risks should generally not 

be assumed to exceed the benchmark 

level of concern of 1 x 10-6 until the 

calculated risks exceed approximately 3 

x 10-6. Therefore, the Agency considers 

this risk estimate to be negligible 

because it falls within the range of 1 in 

1 million. In addition, the cancer risk 

estimate for fenbuconazole is overstated due to very conservative exposure 

assumptions. The exposure estimate 

used in the cancer risk assessment 

assumes that 100 percent of crops 

covered by tolerances are treated and 

that all crops contain residues at the 

highest per-study-volume average 

residue found in crop field trials using 

maximum, or greater than maximum, 

permitted application amounts. 

5. Determination of safety. Based on 

these risk assessments, EPA therefore 

concludes that there is a reasonable 

certainty that no harm will result to the 

general population, infants, or children 

from aggregate exposure to 

fenbuconazole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with nitrogenphosphorus detection) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

Codex MRL’s are established on 

bananas and pecans at 0.05 ppm, wheat 

grain at 0.1 ppm, peach at 0.5 ppm, 

cherries at 1.0 ppm, and wheat straw at 

3.0 ppm. Although the residue 

definitions differ (i.e., Codex does not 

include the metabolites), the U.S. 

tolerances for pecans and wheat grain 

match the Codex limits numerically. 

The U.S. stone fruit crop group 

tolerance of 1.0 ppm is consistent with 

the highest Codex MRL on an individual 

member (cherries) of that crop group. In 

the cases of bananas and wheat straw, 

the levels of total residues in the U.S. 

tolerance expression (which includes 

fenbuconazole metabolites) are higher 

than the Codex MRL (which excludes 

these metabolites). Therefore, EPA has 

not harmonized these values. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of fenbuconazole, 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55299 

a-(2-(4-chlorophenyl)-ethyl)-a-phenyl-3- 

(1H-1,2,4-triazole)-1-propanenitrile and 

its metabolites cis-5-(4-chlorophenyl)- 

dihydro-3-phenyl-3-(1H-1,2,4-triazole-1- 

ylmethyl)-2-3H-furanone and trans-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3Hfuranone, expressed as fenbuconazole, 

in or on almond at 0.05 ppm; almond, 

hulls at 1.0 ppm; apple at 0.4 ppm; 

apple, wet pomace at 1.0 ppm; banana 

at 0.3 ppm; beet, sugar, dried pulp at 1.0 

ppm; beet, sugar, molasses at 0.4 ppm; 

beet, sugar, roots at 0.3 ppm; beet, sugar, 

tops at 9.0 ppm; bushberry subgroup 

13B at 0.3 ppm; cattle, meat byproducts 

at 0.05 ppm; citrus, dried pulp at 5.0 

ppm; citrus, oil at 40.0 ppm; cranberry 

at 0.5 ppm; fruit, citrus, group 10 at 1.0 

ppm; fruit, stone, group 12 at 1.0 ppm; 

goat, meat byproducts at 0.05 ppm; 

grain, aspirated fractions at 6.0 ppm; 

grape at 1.0 ppm; horse, meat 

byproducts at 0.05 ppm; peanut at 0.1 

ppm; pecan at 0.05 ppm; sheep, meat 

byproducts at 0.05 ppm; wheat, forage at 

4.0 ppm; wheat, grain at 0.1 ppm; 

wheat, hay at 8.0 ppm; and wheat, straw 

at 8.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 13, 2006. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.480 is amended in 

paragraph (a)(1) by revising the table 

and in paragraph (b), in the table, by 

removing the commodities cattle, meat 

byproducts; goat, meat byproducts; 

grapefruit; grapefruit, dried pulp; 

grapefruit, oil; horse, meat by products; 

and sheep, meat byproducts. 

The amendment reads as follows: 

§ 180.480 Fenbuconazole; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per million 

Almond ............................ 0.05 

Almond, hulls .................. 1.0 

Apple ............................... 0.4 

Apple, wet pomace ......... 1.0 


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55300 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

Commodity Parts per million 

Banana ........................... 0.3 

Beet, sugar, dried pulp ... 1.0 

Beet, sugar, molasses .... 0.4 

Beet, sugar, roots ........... 0.3 

Beet, sugar, tops ............ 9.0 

Bushberry subgroup 13B 0.3 

Cattle, meat byproducts 0.05 

Citrus, dried pulp ............ 5.0 

Citrus, oil ......................... 40.0 

Cranberry ........................ 0.5 

Fruit, citrus, group 10 ..... 1.0 

Fruit, stone, group 12 ..... 1.0 

Goat, meat byproducts ... 0.05 

Grain, aspirated fractions 6.0 

Grape1 ............................ 1.0 

Horse, meat byproducts 0.05 

Peanut ............................ 0.1 

Pecan .............................. 0.05 

Sheep, meat byproducts 0.05 

Wheat, forage ................. 4.0 

Wheat, grain ................... 0.1 

Wheat, hay ..................... 8.0 

Wheat, straw ................... 8.0 

1There are no United States registrations for 

grape as of August 2006. 

* * * * * 

[FR Doc. 06–7957 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0347; FRL–8092–1] 

Propiconazole; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes or 

revises tolerances for combined residues 

of propiconazole and its metabolites 

containing the dichlorobenzoic acid 

(DCBA) moiety expressed as parent 

compound in or on various 

commodities; and inadvertent residues 

in or on alfalfa, forage and alfalfa, hay. 

Syngenta Crop Protection, Inc. and 

Interregional Research Project No. 4 (IR4), requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 22, 2006. Objections and 

requests for hearings must be received 

on or before November 21, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0347. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S-4400, 

One Potomac Yard (South Building), 

2777 S. Crystal Drive, Arlington, VA. 

The Docket Facility is open from 8:30 

a.m. to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Mary Waller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2006–0347 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 21, 2006. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0347, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S-4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 


rwilkins on PROD1PC63 with RULES_1